Mechelen, Flemish Region, Belgium
Nearly 10 years in safety-critical medical device software — from hands-on embedded engineering through people management to cross-functional program delivery. I've led teams of up to 10 engineers on Class III devices, coordinated 17 engineers across Italy and India, and owned end-to-end program execution including FDA submissions and regulatory compliance under IEC 62304, ISO 13485, and ISO 14971. My most defining moment: leading the recovery of a failed FDA submission at Mozarc Medical, coordinating embedded and application teams, QA, and Regulatory to deliver the complete software documentation package that enabled a 10-patient clinical study. I also pioneered the first cybersecurity penetration test submission for the device — with no prior organizational playbook. I made a deliberate move to Cochlear as Software Product Owner to broaden my perspective beyond embedded software — understanding how regulated application software is delivered, how cross-functional backlog ownership works at scale, and how to manage delivery across teams with mixed technical stacks. It's a foundation I was missing and now have. I'm now looking for a role that integrates both dimensions: program or engineering leadership across the full software stack in a regulated medical device environment. PRINCE2 Foundation. MSc Biomedical Engineering, Politecnico di Torino. Open to relocation across Europe, the US, or the UK.